Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

546

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2010

Conditions
Pancreatic Neoplasm
Interventions
DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.

DRUG

Placebo

4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle

DRUG

Gemcitabine

1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.

Trial Locations (24)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Buenos Aires

Sanofi-Aventis Administrative Office, Vienna

Sanofi-Aventis Administrative Office, Diegem

Sanofi-Aventis Administrative Office, Sofia

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Santiago

Sanofi-Aventis Administrative Office, Bogotá

Sanofi-Aventis Administrative Office, Nicosia

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Berlin

Sanofi-Aventis Administrative Office, Athens

Sanofi-Aventis Administrative Office, Budapest

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, México

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, San Juan

Sanofi-Aventis Administrative Office, Bucharest

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Brastislava

Sanofi-Aventis Administrative Office, Barcelona

Sanofi-Aventis Administrative Office, Geneva

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY